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Physical Training in Patients With Idiopathic Inflammatory Myopathies

Primary Purpose

Idiopathic Inflammatory Myopathies, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Physical exercises
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Idiopathic Inflammatory Myopathies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Diagnosis of DM / PM according to the criteria of Bohan and Peter (1975)
  • Both genders and age ≥ 18 years
  • Use of prednisone ≤ 0.5 mg/kg/day in the last three months. The dose of prednisone will be kept fixed throughout the study
  • Physically inactive

Exclusion Criteria:

  • Disease relapsing
  • Neoplasia associated-myositis
  • Overlapping myositis
  • Use of lipid-lowering drugs
  • Smoking
  • Diabetes mellitus

Sites / Locations

  • Samuel Katsuyuki Shinjo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

No Intervention

Arm Label

Case

Control

Healthy control

Arm Description

Patients: this group will be submitted to 12-weeks, twice/week, physical exercises.

Patients: this group will not be submitted to 12-weeks, twice/week, physical exercises.

Volunteers: this group will not be submitted to 12-weeks, twice/week, physical exercises.

Outcomes

Primary Outcome Measures

Cardiopulmonary test
Patients will undertake a maximal graded exercise test on a treadmill, with increments in velocity and grade at every minute until volitional exhaustion. VO2peak will be considered as the average of the final 30 s of the test. Ventilatory threshold (VAT) will be determined when ventilatory equivalent for VO2 (VE/VO2) increased without a concomitant increase in ventilatory equivalent for carbon dioxide (VE/VCO2). Respiratory compensation point (RCP) will be determined when VE/VO2 and VE/VCO2 increased simultaneously.

Secondary Outcome Measures

Serum cytokines
Blood samples will be centrifuged at 3000 rpm for 15 min at 4°C, and the serum aliquot will be stored at -80°C for subsequent analyses. Cytokines (i.e., IL-6, TNF alpha, IFN gamma) will be measured using a multiplex human panel (Milliplex Map, Millipore, Billerica, MA, USA). Data analysis will be performed through Luminex xMAP Technology, according to the manufacturer's instructions.
Strength muscle tests
The dynamic 1-RM for the leg-press and the bench-press exercises, arm curl (with the dominant arm).
Muscle biopsies
After local anesthesia, a cutaneous incision will be made in lateral thigh face. The biopsy will be done using the Bergstrom needle. Histological (hematoxylin and eosin)/immunohistochemical (CD4, CD8, CD68, CD20, C5b-9, MHCI, MHCII, CD31) analysis will be performed in muscle samples (at baseline and after 12 weeks) in all patients (present study)
Functional muscle tests
Isometric strength (assessed by handgrip, with the dominant arm) will be assessed at baseline and after the intervention. Muscle function will be evaluated through the TUG and the TST tests.
Myositis Disease Activity Assessment Tool
This partially validated tool measures the degree of disease activity of extra-muscular organ systems and muscle. This is a combined tool that includes the Myositis Disease Activity Assessment Visual Analogue Scales (MYOACT), which is a series of physician's assessments of disease activity, and the Myositis Intention to Treat Activity Index (MITAX).
Muscle enzymes
This partially validated tool measures the serum activities of at least 2 of the 4 muscle-associated enzymes including creatine phosphokinase (CK), the transaminases (ALT, AST), lactate dehydrogenase (LD) and aldolase.
Health Assessment Questionnaire
Especific questionnaire (health assessment questionnaire). Pontuaction 0.00-3.00
Manual Muscle Testing
This partially validated tool assesses muscle strength using manual muscle testing (MMT). A 0 - 10 point scale is proposed for use. An abbreviated group of 8 proximal, distal, and axial muscles performs similarly to a total of 24 muscle groups, and is also proposed for use for research studies.
Patient/Parent Global Activity
This partially validated tool measures the global evaluation by the patient, or by the parent if the patient is a minor, of the patient's overall disease activity at the time of assessment using a 10 cm. visual analogue scale.
Physician Global Activity
This partially validated tool measures the global evaluation by the treating physician of the overall disease activity of the patient at the time of assessment using a 10 cm. visual analogue scale and a 5 point Likert scale.

Full Information

First Posted
March 9, 2017
Last Updated
April 29, 2021
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03092167
Brief Title
Physical Training in Patients With Idiopathic Inflammatory Myopathies
Official Title
Physical Training in Patients With Idiopathic Inflammatory Myopathies
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
April 29, 2021 (Actual)
Study Completion Date
April 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Physical training may improve physical capacity and health parameters in various systemic autoimmune diseases, including idiopathic inflammatory myopathies. Therefore, the present study will assess the role of an exercise training program in patients with idiopathic inflammatory myopathies.
Detailed Description
To assess the impact of 12-weeks of physical training in patients with idiopathic inflammatory myopathies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Inflammatory Myopathies, Physical Activity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
15 idiopathic inflammatory myopathies submmited to physical exercises 15 idiopathic inflammatory myopathies not submmited to physcial exercises 10 healthy individuals
Masking
None (Open Label)
Masking Description
Open label
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Case
Arm Type
Active Comparator
Arm Description
Patients: this group will be submitted to 12-weeks, twice/week, physical exercises.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients: this group will not be submitted to 12-weeks, twice/week, physical exercises.
Arm Title
Healthy control
Arm Type
No Intervention
Arm Description
Volunteers: this group will not be submitted to 12-weeks, twice/week, physical exercises.
Intervention Type
Other
Intervention Name(s)
Physical exercises
Intervention Description
Physical exercises
Primary Outcome Measure Information:
Title
Cardiopulmonary test
Description
Patients will undertake a maximal graded exercise test on a treadmill, with increments in velocity and grade at every minute until volitional exhaustion. VO2peak will be considered as the average of the final 30 s of the test. Ventilatory threshold (VAT) will be determined when ventilatory equivalent for VO2 (VE/VO2) increased without a concomitant increase in ventilatory equivalent for carbon dioxide (VE/VCO2). Respiratory compensation point (RCP) will be determined when VE/VO2 and VE/VCO2 increased simultaneously.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Serum cytokines
Description
Blood samples will be centrifuged at 3000 rpm for 15 min at 4°C, and the serum aliquot will be stored at -80°C for subsequent analyses. Cytokines (i.e., IL-6, TNF alpha, IFN gamma) will be measured using a multiplex human panel (Milliplex Map, Millipore, Billerica, MA, USA). Data analysis will be performed through Luminex xMAP Technology, according to the manufacturer's instructions.
Time Frame
12 weeks
Title
Strength muscle tests
Description
The dynamic 1-RM for the leg-press and the bench-press exercises, arm curl (with the dominant arm).
Time Frame
12 weeks
Title
Muscle biopsies
Description
After local anesthesia, a cutaneous incision will be made in lateral thigh face. The biopsy will be done using the Bergstrom needle. Histological (hematoxylin and eosin)/immunohistochemical (CD4, CD8, CD68, CD20, C5b-9, MHCI, MHCII, CD31) analysis will be performed in muscle samples (at baseline and after 12 weeks) in all patients (present study)
Time Frame
12 weeks
Title
Functional muscle tests
Description
Isometric strength (assessed by handgrip, with the dominant arm) will be assessed at baseline and after the intervention. Muscle function will be evaluated through the TUG and the TST tests.
Time Frame
12 weeks
Title
Myositis Disease Activity Assessment Tool
Description
This partially validated tool measures the degree of disease activity of extra-muscular organ systems and muscle. This is a combined tool that includes the Myositis Disease Activity Assessment Visual Analogue Scales (MYOACT), which is a series of physician's assessments of disease activity, and the Myositis Intention to Treat Activity Index (MITAX).
Time Frame
12 weeks
Title
Muscle enzymes
Description
This partially validated tool measures the serum activities of at least 2 of the 4 muscle-associated enzymes including creatine phosphokinase (CK), the transaminases (ALT, AST), lactate dehydrogenase (LD) and aldolase.
Time Frame
12 weeks
Title
Health Assessment Questionnaire
Description
Especific questionnaire (health assessment questionnaire). Pontuaction 0.00-3.00
Time Frame
12 weeks
Title
Manual Muscle Testing
Description
This partially validated tool assesses muscle strength using manual muscle testing (MMT). A 0 - 10 point scale is proposed for use. An abbreviated group of 8 proximal, distal, and axial muscles performs similarly to a total of 24 muscle groups, and is also proposed for use for research studies.
Time Frame
12 weeks
Title
Patient/Parent Global Activity
Description
This partially validated tool measures the global evaluation by the patient, or by the parent if the patient is a minor, of the patient's overall disease activity at the time of assessment using a 10 cm. visual analogue scale.
Time Frame
12 weeks
Title
Physician Global Activity
Description
This partially validated tool measures the global evaluation by the treating physician of the overall disease activity of the patient at the time of assessment using a 10 cm. visual analogue scale and a 5 point Likert scale.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnosis of DM / PM according to the criteria of Bohan and Peter (1975) Both genders and age ≥ 18 years Use of prednisone ≤ 0.5 mg/kg/day in the last three months. The dose of prednisone will be kept fixed throughout the study Physically inactive Exclusion Criteria: Disease relapsing Neoplasia associated-myositis Overlapping myositis Use of lipid-lowering drugs Smoking Diabetes mellitus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel K Shinjo, PhD
Organizational Affiliation
Universidade de Sao Paulo - Rheumatology Division
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samuel Katsuyuki Shinjo
City
Sao Paulo
ZIP/Postal Code
01246903
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34227790
Citation
Borges IBP, de Oliveira DS, Marie SKN, Lenario AM, Oba-Shinjo SM, Shinjo SK. Exercise Training Attenuates Ubiquitin-Proteasome Pathway and Increases the Genes Related to Autophagy on the Skeletal Muscle of Patients With Inflammatory Myopathies. J Clin Rheumatol. 2021 Sep 1;27(6S):S224-S231. doi: 10.1097/RHU.0000000000001721.
Results Reference
derived

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Physical Training in Patients With Idiopathic Inflammatory Myopathies

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